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FDA 510(k), K173388, Exactech Equinoxe Stemless Shoulder
FDA 510(k), K173388, Exactech Equinoxe Stemless Shoulder
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$149.00 USD
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510(K) Number: K173388
Device Name: Exactech Equinoxe Stemless Shoulder
Manufacturer: Thomas McNamara
Device Classification Name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation Number: PKC
Classification Product Code: 10/30/2017
Date Received: 03/09/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Exactech Equinoxe Stemless Shoulder
Manufacturer: Thomas McNamara
Device Classification Name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation Number: PKC
Classification Product Code: 10/30/2017
Date Received: 03/09/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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